Clinical Trial Updates

A look at the ongoing clinical trials in multiple myeloma.

PHASE III TRIALS

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (NCT01564537)

  • Study Design: Randomized, double- blind, parallel assignment safety/efficacy study
  • Study Start Date: August 2012
  • Estimated Study Completion Date: May 2019
  • Study Status: This study is ongoing, but not recruiting participants.
  • Estimated Enrollment: 837
  • Sponsor: Millennium Pharmaceuticals, Inc.

This trial compares the use of ixazomib (the first oral proteasome inhibitor) in combination with lenalidomide and weekly dexamethasone with the standard of care. Once again, this three-drug regimen is first being studied in the relapsed/refractory multiple myeloma population, but trials in newly diagnosed patients are also underway. A positive study would launch the first oral combination therapy incorporating the most active targeted pathways in this disease – with the potential to dramatically improve convenience for patients. Ixazomib is also being investigated in newly diagnosed multiple myeloma (NCT01850524) and as maintenance therapy in patients with multiple myeloma following autologous stem cell transplantation (NCT02181413).


Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT – 1) (NCT01335399)

  • Study Design: Randomized, open-label, parallel assignment efficacy study
  • Study Start Date: May 2011
  • Estimated Study Completion Date: July 2020
  • Study Status: This study is ongoing, but not recruiting participants.
  • Estimated Enrollment: 750
  • Sponsor: Bristol-Myers Squibb

The purpose of this study is to determine whether the addition of elotuzumab to lenalidomide and low-dose dexamethasone will increase the progression-free survival compared with lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed multiple myeloma.


Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106) (NCT01208662)

  • Study Design: Randomized, open-label, parallel assignment safety/efficacy study
  • Study Start Date: September 2010
  • Estimated Study Completion Date: September 2018
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 660
  • Sponsor: Dana-Farber Cancer Institute

This study is exploring the safety and efficacy of the combination of lenalidomide, bortezomib, and dexamethasone alone or when combined with autologous stem cell transplantation in patients with newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high-dose therapy is still necessary in the initial management of multiple myeloma in younger patients. In this study, high-dose therapy will be considered superior to conventional-dose treatment if it prolongs progression-free survival by at least nine months or more.


Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma (NCT02252172)

  • Study Design: Randomized, open-label, parallel assignment efficacy study
  • Study Start Date: February 2015
  • Estimated Study Completion Date: November 2022
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 730
  • Sponsor: Janssen Research & Development, LLC

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone with that of lenalidomide and dexamethasone in terms of progression-free survival (the primary endpoint) in patients with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy autologous hematopoietic cell transplantation.


A Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-Weekly Versus Twice-Weekly Carfilzomib Dosing (ARROW) (NCT02412878)

  • Study Design: Randomized, open-label, parallel assignment safety/efficacy study
  • Study Start Date: April 2015
  • Estimated Study Completion Date: September 2018
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 460
  • Sponsor: Onyx Pharmaceuticals

The ARROW trial is comparing two dosing regimens of the proteasome inhibitor carfilzomib: once-weekly carfilzomib dosing in combination with dexamethasone, and twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma who had been previously treated with bortezomib and an immunomodulatory agent.


Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT01863550)

  • Study Design: Randomized, open-label, parallel assignment efficacy study
  • Study Start Date: November 2013
  • Estimated Study Completion Date: May 2016
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 756
  • Sponsor: Eastern Cooperative Oncology Group

This randomized phase III trial is comparing the combination of bortezomib, lenalidomide, and dexamethasone with the combination of carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma.


PHASE II TRIALS

Phase 2b Open-Label Single-Arm Study With KPT-330 + Dexamethasone in Patients w/ Quad-Refractory Multiple Myeloma (STORM) (NCT02336815)

  • Study Design: Single cohort, open-label pilot study
  • Study Start Date: May 2015
  • Estimated Study Completion Date: November 2016
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 80
  • Sponsor: Karyopharm Therapeutics, Inc.

This is a potential registration trial of selinexor, a novel small molecule inhibitor targeting the nuclear transport protein exportin (XPO-1, also known as CRM-1) in multiple myeloma. Early reports of single-agent activity, as well as a 60 percent response rate in a study of 10 refractory patients who received selinexor plus dexamethasone, prompted the design of this trial, which will look at the safety and efficacy of selinexor in heavily treated patients with an unmet medical need.


Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma (NCT01323751)

  • Study Design: Open-label, single-group assignment safety/efficacy study
  • Phase: I/II
  • Study Start Date: July 2011
  • Estimated Study Completion Date: September 2015
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 120
  • Sponsor: Acetylon Pharmaceuticals Incorporated; Leukemia and Lymphoma Society

Phase Ia and Ib of this trial will evaluate the safety and optimal dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Phase IIa will determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in these patients.


PHASE I TRIALS

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients (PomdeSAR) (NCT02283775)

  • Study Design: Open-label, single-group assignment safety study
  • Study Start Date: March 2015
  • Estimated Study Completion Date: January 2017
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 24
  • Sponsor: Sanofi

SAR650984 is a monoclonal antibody targeting CD38 that is now being studied in phase II combination studies, such as this recently opened trial combining SAR650984 with pomalidomide and dexamethasone.


Safety Study in Nivolumab Alone and in Combination With Ipilimumab or Lirilumab in Lymphoma and Multiple Myeloma (NCT01592370)

  • Study Design: Non-randomized, open-label, single-group assignment safety study
  • Study Start Date: June 2012
  • Estimated Study Completion Date: March 2018
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 315
  • Sponsor: Bristol-Myers Squibb

This ongoing study is designed to determine the side effects of the PD-1 inhibitor nivolumab alone and in combination with ipilimumab or lirilumab. In a recent report by Ansell et al. published in The New England Journal of Medicine, nivolumab demonstrated strong response rates and acceptable safety in a cohort of 23 patients with relapsed or refractory Hodgkin lymphoma. Results were also presented at the 2014 ASH Annual Meeting. These heavily treated patients had few other therapeutic options available – 78 percent had relapsed after autologous stem cell transplantation, and 78 percent had relapsed after treatment with brentuximab vedotin. Response rates were high: 20 patients (87%) experienced an objective response, including 17 percent with a complete response and 70 percent with a partial response. Adverse events were mainly low grade, with no life-threatening adverse events. Based on these findings – which support nivolumab-mediated PD-1 blockade as a promising targeted treatment for these patients – the FDA has granted nivolumab breakthrough status and a multinational phase II trial is underway.


Dinaciclib, Bortezomib, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma (NCT01711528)

  • Study Design: Non-randomized, open-label, parallel assignment safety study
  • Study Start Date: December 2012
  • Estimated Study Completion Date: June 2016
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 60
  • Sponsor: National Cancer Institute

This trial will establish the safety profile and optimal dose of the combination of dinaciclib (a novel cyclin-dependent kinase inhibitor) and bortezomib, plus dexamethasone, in treating patients with relapsed disease. Dinaciclib has demonstrated single-agent activity in this setting; combining it with bortezomib and dexamethasone may kill more cancer cells.


Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma (NCT02215967)

  • Study Design: Open-label, single-group assignment safety study
  • Study Start Date: August 2014
  • Estimated Study Completion Date: April 2019
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 38
  • Sponsor: National Cancer Institute

Engineered T cells have shown to be safe and result in durable responses in patients with relapsed and treatment-resistant blood cancers. This trial will test the safety of anti-B-cell maturation antigen T cells in patients with multiple myeloma who have not responded to standard therapies.

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